Generic substitution of antiretrovirals: patients’ and health care providers’ opinions

Abstract

There is interest in introducing generic antiretroviral drugs (ARVs) into high-income countries in order to maximise efficiency in health care budgets. Studies examining patients’ and providers’ knowledge and attitudes to generic substitution in HIV are few. This was a cross-sectional, observational study with a convenience sample of adult HIV-infected patients and health care providers (HCPs). Data on demographics, knowledge of generic medicine and facilitators of generic substitution were collected. Descriptive and univariate analysis was performed using SPSS V.23™. Questionnaires were completed by 66 patients. Seventy-one per cent would have no concerns with the introduction of generic ARVs. An increase in frequency of administration (61%) or pill burden (53%) would make patients less likely to accept generic ARVs. There were 30 respondents to the HCP survey. Concerns included the supply chain of generics, loss of fixed dose combinations, adherence and use of older medications. An increase in dosing frequency (76%) or an increase in pill burden (50%) would make HCPs less likely to prescribe a generic ARV. The main perceived advantage was financial. Generic substitution of ARVs would be acceptable to the majority of patients and HCPs. Reinvesting savings back into HIV services would facilitate the success of such a programme.

De‐simplifying single‐tablet antiretroviral treatments: uptake, risks and cost savings

“…The use of generic ARV drugs may offer one potential route for controlling rising costs while maintaining quality of care. We identified no voiced concerns regarding generic drug use, safety or efficacy, contrasting with concerns regarding generic drugs expressed elsewhere [28,29], and found that acceptability was similar to that in other reports [22,33]. Although the study was not randomized, we could find no signal of decreased antiviral efficacy or intolerances in those choosing gK/T.…”

“…Walensky et al [18] projected a potential saving of > US$1 billion from de-simplifying one commonly used branded STF regimen. However, diverse concerns of both physicians and patients about the efficacy of generic drugs, the increase in pill burden, the risk of switching successful regimens, and patient acceptability may impact the uptake and use of generic ART [25][26][27][28][29][30][31][32][33][34]. Increasing pill burden may be seen as a step back [35][36][37].…”

Budget Impact Analysis Highlighting the Cost-Saving Potential of Generic Tenofovir Disoproxil Based Antiretroviral Therapy in Comparison with Tenofovir Alafenamide Based Treatment Regimens in the German Healthcare System

“…Interestingly, both patients and prescribers are open-minded and willing to share generic medicines [52]. Coincidentally, in two studies, about half of the patients, Engelhard et al [56] and Krentz et al [57] declared their consent to an exchange of elements of their cART even with a higher number of tablets, if the advantage would not only be theirs but a cost saving for their health insurance.…”

“…Owing to the special requirements for consistent compatibility and effectiveness of cART, a continuing controversy concerns the safety of a substance exchange even in the case of generics with identical active ingredients [50][51][52]. Some studies have described risks for sustainability of virological control by cART when the generic drug was associated with a higher number of pills [50,53].…”

Effectiveness and tolerability of dolutegravir and abacavir/lamivudine administered as two separate pills compared to their equivalent single‐tablet regimen in a multicentre cohort in Spain

“…Therefore, changing branded STRs for their equivalent generic components often entails administering them as at least two separate pills (these changes are known as “de‐simplifying STRs” or “breaking the combos”). These changes are controversial, and several studies have shown that, while most HIV care clinicians agree on using generic ARVs to decrease healthcare costs, many of them do not agree to de‐simplify STRs, mainly because of concerns of potential decreased treatment adherence [ 10 , 11 , 12 ].…”